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BioXcel Therapeutics, Inc. (NASDAQ:BTAI) announced Tuesday that the United States Patent and Trademark Office has allowed U.S. Patent Application No. 18/600,419. The allowed claims cover the administration of a single dose of up to 120 micrograms of dexmedetomidine in an oromucosal formulation for treating acute agitation associated with schizophrenia or bipolar disorder in certain patient subpopulations. These subpopulations are defined as patients exhibiting a maximum allowed QT prolongation of less than six microseconds. The company, currently valued at $12.23 million, has faced significant challenges with its stock price declining nearly 90% over the past year.
According to the company’s statement, the allowed claims mirror the recommended dosing regimen for IGALMI in patients who meet this QT prolongation criterion. Once issued, the patent will be eligible for listing in the U.S. Food and Drug Administration’s Orange Book for IGALMI and will become the 14th Orange Book-listed patent for this product.
The patent is expected to have an expiry date of January 12, 2043, subject to any patent term adjustments. The information is based on a press release statement included in the company’s SEC filing.
In other recent news, BioXcel Therapeutics has announced significant progress in its SERENITY At-Home Phase 3 trial for the BXCL501 treatment. The independent Data Safety Monitoring Board (DSMB) has recommended continuing the trial without modifications after reviewing safety data from 178 patients, marking the second positive recommendation for this study. The trial, fully enrolled with over 205 patients, is evaluating the safety of BXCL501 for treating agitation associated with bipolar disorders or schizophrenia in home settings. H.C. Wainwright has maintained a Buy rating on BioXcel, raising the stock’s price target to $8.00 from $3.00, citing these positive developments. The firm considers the upcoming data readout low-risk and anticipates a potential label expansion for BXCL501’s commercial name, IGALMI, by the end of 2025. Additionally, BioXcel Therapeutics has been granted an extension by The Nasdaq Stock Market LLC to comply with the Minimum Value of Listed Securities Rule by September 16, 2025. This extension is crucial for maintaining its Nasdaq listing. The company continues to leverage artificial intelligence in its drug development efforts, aiming to transform treatment landscapes in neuroscience and immuno-oncology.
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